BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

    K Number: K002255 · Decision Sep 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
    K Number
    K002255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wolfe Tory Medical, Inc.
    Date Received
    July 25, 2000
    Decision Date
    September 18, 2000
    Product Code
    CCT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCT Applicator (Laryngo-Tracheal), Topical Anesthesia

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